青海省药品生产企业检验检测能力评估与提升对策研究OA

Objective:To evaluate the current inspection and testing capabilities of pharmaceutical manufacturers in Qinghai Province,identify issues in personnel structure,equipment configuration,management systems,and compliance,and provide evidence for improving regional drug quality and safety,promoting high quality development of the pharmaceutical industry,and optimizing regulatory strategies.Methods:A comprehensive survey was conducted on 40 pharmaceutical manufacturers in the province using a combination of question-naire based self-assessment and on site verification.The survey covered laboratory construction,functional zoning,types and status of tes-ting equipment,professional background and training of testing personnel,implemented testing items,and models of commissioned tes-ting.Results and Conclusion:The overall inspection and testing capabilities of pharmaceutical manufacturers in Qinghai Province remain at a developing stage,with deficiencies in personnel,equipment,and management.Influenced by multiple factors such as limited corpo-rate awareness,insufficient funding,dispersed geographical distribution,and imperfect management support systems,the testing capabili-ties of some enterprises fail to fully meet the rising requirements for drug quality standards,thereby adversely affecting drug quality control.Enterprises should adopt a quality oriented development philosophy and continuously increase investment in the recruitment of professional talents,technical training,and advanced testing equipment.Meanwhile,drug regulatory authorities should further strengthen industrial sup-port and guidance,and comprehensively enhance the quality and safety assurance capacity of the pharmaceutical industry chain through measures such as establishing a regional inspection and testing resources haring platform and improving the intelligent regulatory system.